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2026 data FDA MAUDE openFDA FDA Class II

Suture, Absorbable, Synthetic, Polyglycolic Acid

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §878.4493 (General, Plastic Surgery panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Suture MID-BOOK · MAUDE

#63 of 1000 · 56,265 reports · 1994–2026

  • BOOK 56,265 reports
  • RANK #63 of 1000
  • DEATH 88 death-typed
  • INJ 13,042 injury-typed
  • MALF 42,975 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 9,119
  • PHOTO Pacemaker/Icd/Crt Non…

Nearest event-volume peer: Pacemaker/Icd/Crt Non-Implanted Components (357 report gap)

Suture, Absorbable, Synthetic, Polyglycolic Acid sits #63 of 1000 among tracked device types with 56,265 MAUDE reports spanning 1994–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Suture carries 76.4% MALFUNCTION-coded reports, 11.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 23.2% corpus 30.3% · below corpus mean (-7.1 pp)
  • MALF 76.4% corpus 64.8% · above corpus mean (+11.6 pp)

Lead product-problem code Break is 37% of coded problems · Lead manufacturer ETHICON INC. accounts for 59% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Suture in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Suture, Absorbable, Synthetic, Polyglycolic Acid carries 56,265 MAUDE reports, ranked #63 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 42,975 (76.4%)
Injury 13,042 (23.2%)
Other 90 (0.2%)
Death 88 (0.2%)
70 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

41,192 (72.3%)
Required Intervention 9,824 (17.2%)
Other 4,128 (7.2%)
R 733 (1.3%)
Hospitalization 516 (0.9%)
O 244 (0.4%)
H 120 (0.2%)
Death 71 (0.1%)
Life Threatening 31 (0.1%)
L 26 (0.0%)
S 26 (0.0%)
Disability 25 (0.0%)
D 19 (0.0%)
Congenital Anomaly 10 (0.0%)
Invalid Data 2 (0.0%)
C 1 (0.0%)

Top Product Problems

Break 20,391
Material Separation 10,531
Detachment of Device or Device Component 8,962
Adverse Event Without Identified Device or Use Problem 5,379
Other (for use when an appropriate device code cannot be identified) 1,496
Appropriate Device Problem Term/Code Not Available 1,124
Needle, separation 956
Material Integrity Problem 919
Material Frayed 699
Insufficient Device Problem Information 640
Reaction 614
Patient-Device Incompatibility 611
Detachment Of Device Component 558
Unraveled Material 547
Unknown (for use when the device problem is not known) 514
Failure To Adhere Or Bond 389
Suture line disruption 389
Material Split, Cut or Torn 387
Device Markings/Labelling Problem 343
Explanted 341

Yearly Trend

94
1994: 17
95
1995: 25
96
1996: 99
97
1997: 417
98
1998: 155
99
1999: 159
00
2000: 174
01
2001: 379
02
2002: 221
03
2003: 145
04
2004: 178
05
2005: 156
06
2006: 172
07
2007: 274
08
2008: 194
09
2009: 287
10
2010: 587
11
2011: 637
12
2012: 868
13
2013: 898
14
2014: 1,410
15
2015: 935
16
2016: 1,112
17
2017: 1,499
18
2018: 2,229
19
2019: 3,564
20
2020: 3,415
21
2021: 4,506
22
2022: 4,814
23
2023: 5,070
24
2024: 7,226
25
2025: 9,119
26
2026: 5,324

Reports rose to 9,119 in 2025, up from an average of 6,148 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Suture, Absorbable, Synthetic, Polyglycolic Acid

Top Manufacturers

ETHICON INC. 29,575
DAVIS & GECK CARIBE LTD 6,304
COVIDIEN LP LLC NORTH HAVEN 5,638
ETHICON, INC. 2,943
COVIDIEN SURGICAL 2,441
B. BRAUN SURGICAL, S.A. 2,426
B. BRAUN SURGICAL S.A. 468

Event Locations

35,710 (63.5%)
I 15,168 (27.0%)
HOSPITAL 3,218 (5.7%)
OTHER 1,084 (1.9%)
UNKNOWN 667 (1.2%)
NO INFORMATION 233 (0.4%)
INVALID DATA 70 (0.1%)
HOME 69 (0.1%)
OUTPATIENT TREATMENT FACILITY 20 (0.0%)
AMBULATORY SURGICAL FACILITY 13 (0.0%)
AMBULATORY SURGICAL CENTER 7 (0.0%)
OPERATING ROOM 3 (0.0%)
HOSPICE 2 (0.0%)
NURSING HOME 1 (0.0%)

Compare ETHICON INC. vs DAVIS & GECK CARIBE LTD →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Suture: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (56,265 here).

Pacemaker/Icd/Crt Non-Implanted Components 55,908 Implantable Pacemaker Pulse-Generator 57,769 Screw, Fixation, Bone 58,626 Stimulator 52,959

Similar death-typed counts

Nearest other device types by death-typed report count (88 here), distinct from the volume row.

Surgical Device 86 Thoracolumbosacral Pedicle Screw System 86 Pulse-Generator, Pacemaker, External 85 Pump, Infusion, Enteral 85

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Suture are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Suture; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.